FDA Urged to Make Oysters Safe

CSPI Says Agency Should Use New Food Safety Law to Protect Consumers From Deadly Vibrio Bacteria

February 9, 2012

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Mark your calendar: Between April and November, about 30 Americans will get seriously sick and approximately 15 will die after eating raw oysters or other shellfish contaminated with deadly Vibrio vulnificus bacteria. These contaminated oysters are mainly harvested from the Gulf Coast region, especially during the warmer summer months. Today the nonprofit Center for Science in the Public Interest is urging the Food and Drug Administration to set a performance standard for the shellfish industry that would reduce this threat to consumers. CSPI says FDA should act now, before the increase in Gulf Coast water temperatures creates a more hospitable environment for the naturally occurring but deadly contaminant.

Raw or undercooked oysters are the primary Vibrio culprits. Symptoms include the classic signs of foodborne illness but for some consumers, the illness can progress to ulcerous skin lesions and septicemia. Almost half of those reporting these more serious infections die and those that survive can suffer lifetime infirmities. Those most at risk include consumers with diabetes, hemochromatosis, compromised immune systems or liver disease. While the shellfish industry resisted a 2009 FDA attempt to require mandatory post-harvest processing of contaminated oysters, the new food safety law signed by President Obama in January 2011 requires the FDA to set performance standards for significant foodborne contaminants like Vibrio vulnificus.

“If we knew a serial killer were going to kill a dozen people like clockwork each year, the police would spring into action to stop it,” said CSPI senior food safety attorney David W. Plunkett. “We know Vibrio vulnificus strikes like clockwork. FDA should use its authority to keep seafood lovers safe from this hazard.”

In 2002, the FDA denied a CSPI regulatory petition calling for a performance standard for Vibrio, citing a voluntary plan to reduce the rate of illnesses coordinated by an Interstate Shellfish Sanitation Conference (ISSC). The regulatory petition CSPI filed today cites the new authority given to the agency by the FDA Food Safety Modernization Act, and the fact that the ISSC’s voluntary plan to reduce illnesses failed to achieve its goals. California, meanwhile, adopted the approach advocated by CSPI in its earlier petition and illnesses and deaths in that state were virtually eliminated.

“Consumers have waited long enough,” CSPI wrote in a letter to FDA Commissioner Margaret Hamburg that accompanied the petition. “In the nine years since FDA denied our original petition, 262 people have suffered serious illnesses including 121 people who died—all of which could have been averted.”

The shellfish industry has a number of commercially viable methods of eliminating Vibrio, including four validated methods for pasteurizing oysters, or it could simply divert contaminated oysters to be cooked. Some restaurateurs and retailers, such as Legal Sea Food and Costco, only sell treated Gulf Coast oysters or oysters harvested from colder waters.